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The products encompassed by this request are intended for in vitro diagnostic use and the quantitative determination of Na", K", and Cl ", on the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the chemistry systems and of the predicate Reagents. The Olympus Chemistry Systems performs a broad array of clinical chemistry tests. The Olympus Chemistry Systems with the ISE module measures sodium (Na), potassium (K), and chloride (Cl ) by Ion Selective Electrodes. These Reagents are intended to be used with the equivalent Olympus Chemistry Systems. As such, ALKO products are intended to serve as direct replacements to like named products manufactured by Olympus .

The Buffer dilutes all measured samples for the quantitative determinations in Na ", K , and Cl in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift in the quantitative determination of Na , K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na ", K", and Cl " electrodes on the Olympus Chemistry System. The Serum High/Low Standard and Urine High/Low Standard are used to calibrate the Na *, K , and Cl clectrodes of the system's ISE module. The ISE Na "/K " Selectivity Na 7, KT, electrode verification. The products Check Solutions are intended for encompassed are to be handled using normal laboratory precautions.

The products encompassed by this 510(k) submission are Class II (75JIX) In Vitro Diagnostic Solutions manufactured by ALKO Diagnostic Corporation, 333 Fiske Street, Holliston, MA 01746. The ISE Reagents are intended for use on the ISE module of the Olympus Chemistry Systems. Olympus America Incorporated is the original equipment manufacturer (OEM) of the system and of predicate ISE Reagents which are necessary for the continued operation and use of the ISE module on these systems.

Information herein will support ALKO's position for the intended use of these products to the Olympus Chemistry System with the ISE module. The ISE module measures Na , K , Cl by using the system's Ion Selective Electrodes. The ALKO Reagents are intended to serve as direct replacements to like named products manufactured by Olympus America Incorporated. The Buffer dilutes all measured samples for the quantitative determinations of Na , K , and Cl concentrations in serum and urine by ISE. The Mid-Standard Solution is intended as a means of compensating for calibration drift. in the quantitative determination of Na K , and Cl in samples on the Olympus Chemistry Systems. The Reference Solution is intended to provide a stable reference potential for Na , K , and Cl electrodes on the Olympus Chemistry Systems. The ISE Serum/Urine and High/Low Standards are used to calibrate the electrodes of Na , K , and Cl on the system's ISE module. The ISE Na /K Selectivity Check Solutions are intended for Na and K electrode verification.

ALKO product A101-100 (ISE Buffer) is equivalent to Olympus Chemistry System product AUH1011 (ISE Buffer). ALKO Product A101-200 (ISE Mid - Standard Solution) is equivalent to Olympus Chemistry System product AUH1012 (ISE Mid-Standard). ALKO product A101-300 (ISE Reference Solution) is equivalent to Olympus Chemistry System product AUH1013 (ISE Reference Solution). ALKO product A101-400 (ISE Low Serum Standard) is equivalent to Olympus Chemistry System product AUH1014 (ISE Low Serum Standard). ALKO product A101-500 (ISE High Serum Standard) is equivalent to Olympus Chemistry System product AUH1015 (ISE High Serum Standard). ALKO product A101-600 (ISE High/Low Urine Standard) is equivalent to Olympus Chemistry System product AUH1016 (ISE High/Low Urine Standard), ALKO product A101-800 (Na7 K Selectivity Check Solution) is equivalent to Olympus Chemisty System product AUH1018 ((Na / K+ Selectivity Check Solution).

ALKO uses a similar composition, description and packaging design as that used by Olympus America in its products.

The ALKO Reagents for the Olympus AU 800™/AU 5200™ Chemistry Systems are intended as direct replacements for Olympus reagents for the quantitative determination of Na+, K+, and Cl- concentrations in serum and urine by Ion Selective Electrodes (ISE).

1. Acceptance Criteria and Reported Device Performance:

The document describes two main types of studies to demonstrate equivalence: Precision Data and Correlation with Olympus Reagents.

Precision Data Acceptance Criteria (Implied):
While explicit acceptance criteria (e.g., maximum allowable CV%) are not stated, the reported precision data for ALKO reagents is expected to be within acceptable limits for clinical laboratory use and comparable to predicate device performance (Olympus reagents). The data shows Coefficient of Variation (CV%) values generally below 1.5% for all analytes across various serum and urine levels, indicating good precision.

Correlation with Olympus Reagents Acceptance Criteria (Implied):
For correlation studies, the acceptance criteria are generally based on:

• Slope: Close to 1.0 (indicating proportional agreement)
• Intercept: Close to 0.0 (indicating no systematic bias)
• R-squared (Correlation Coefficient Squared): Close to 1.0 (indicating strong linear correlation)

Table of Acceptance Criteria (Implied) and Reported Device Performance:

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